NBS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls (K163538) | Inova Diagnostics, Inc. | 2017-09-06 |
| EUROIMMUN ANTI-LKM-1 ELISA(LGG) (K112223) | Euroimmun US | 2012-09-11 |
| QUANTA LITE LKM-1 ELISA (K000535) | Inova Diagnostics, Inc. | 2000-06-07 |
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